Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.

Last updated: March 31, 2025
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Angina

Cardiovascular Disease

Treatment

Sham-procedure

Invasive coronary physiology

Coronary sinus reducer

Clinical Study ID

NCT05492110
21IC7301
  • Ages > 18
  • All Genders

Study Summary

To demonstrate the feasibility and efficacy of the CS Reducer for the treatment of patients with ischaemia and non-obstructed coronary arteries (INOCA) and coronary microvascular dysfunction (CMD) and through a nested mechanistic substudy investigate the physiological responses in the coronary microcirculation responsible for changes in myocardial perfusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >18 years

  2. Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite backgroundtreatment with at least two anti-anginal drug at the maximal tolerated dose.

  3. Patients willing to consider no change in anti-anginal drug treatment for theduration of their participation in the trial.

  4. Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated oncoronary angiography.

  5. Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2).

  6. Willingness to comply with the specified follow-up evaluation and to be contactableduring the period of the trial.

  7. Understands the nature of the trial procedures and provides written informedconsent.

Exclusion

Exclusion Criteria:

  1. Epicardial CAD in a main coronary artery (stenoses >50%, RFR≤0.92 or FFR≤0.80),coronary artery bypass grafting, or myocardial infarction (MI).

  2. Previous PCI within 6 months

  3. PCI with stent insertion for acute MI or chronic total occlusion (CTO)

  4. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent leftsuperior vena cava)

  5. Coronary sinus diameter at site of implant <9.5mm or >13mm

  6. Mean right atrial pressure <15mmHg at time of implantation

  7. Any structural heart disease including left ventricular hypertrophy; cardiomyopathy;severe valvular heart disease; previous valve replacement; myocardial bridge onangiography; LVEF<45% by CMR.

  8. Clinically or angiographically diagnosed coronary vasospasm

  9. Previous hospitalisation for decompensated heart failure

  10. Pacemaker or defibrillator electrode in the right atrium, right ventricle orcoronary sinus

  11. Documented arrhythmia requiring planned implantation of a permanent pacemaker ordefibrillator

  12. Chronic kidney disease (creatinine >200 micromol/L; established on renal replacementtherapy; functioning renal transplant)

  13. Haemoglobin <80g/L

  14. Contraindications to receiving dual antiplatelet therapy

  15. Severe chronic obstructive pulmonary disease (FEV1 <55% predicted)

  16. Moribund patients with life expectancy < 1year

  17. Known allergy to nickel or steel

  18. Current enrolment in another investigational device or drug trial

  19. Contraindications to CMR or receiving intravenous adenosine

  20. Pregnancy

Study Design

Total Participants: 54
Treatment Group(s): 3
Primary Treatment: Sham-procedure
Phase:
Study Start date:
April 17, 2023
Estimated Completion Date:
March 06, 2026

Study Description

Symptomatic angina in patients with ischaemia and non-obstructed coronary arteries (INOCA) is common and associated with increased morbidity and adverse outcomes. Myocardial ischaemia often arises from coronary microvascular dysfunction (CMD). Current treatments are limited, and novel evidence-based therapies are needed to address this large unmet clinical need. The Coronary Sinus Reducer (CS Reducer) is a new treatment for refractory angina, which creates a focal narrowing in the coronary sinus that increases back pressure and redistributes blood into ischaemic myocardium at the level of the microcirculation. However the precise mechanism remains unknown. This study will be a randomised double-blinded sham-controlled pilot study (REMEDY-PILOT) to confirm acceptability of CS Reducer implantation, demonstrate feasibility to recruit and quantify its effect on myocardial perfusion. A nested mechanistic substudy within REMEDY-PILOT will test the hypothesis that CS Reducer implantation alters measures of invasive coronary microcirculatory physiology as the mechanistic basis for observed changes in quantitative CMR stress perfusion, symptoms and quality of life.

Connect with a study center

  • National Heart and Lung Institute (Brompton Campus), Imperial College London

    London, SW36NP
    United Kingdom

    Active - Recruiting

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